The term Pre-Exposure Prophylaxis (PrEP) refers to an HIV prevention practice in which persons not infected with HIV who are at high risk of the disease take antiretroviral medication in an attempt to lower their chances of becoming infected if exposed.

In May 2014, the Centers for Disease Control and Prevention (CDC) released final guidelines on the recommended use of PrEP. The guidelines recommend PrEP for HIV-uninfected patients with any of the following indications:

Is in an ongoing relationship with an HIV-infected partner.

Is not in a mutually monogamous relationship with a partner who recently tested HIV-negative, and who is:

A gay or bisexual man who has had sex without a condom or been diagnosed with a sexually transmitted infection within the past six months.

A heterosexual man or woman who does not regularly use condoms when having sex with partners known to be at risk for HIV (for example, injecting drug users or bisexual male partners of unknown HIV status) or whose partners are from communities with high rates of HIV infection.

Has injected illicit drugs within the past six months and has shared equipment or been in drug treatment within the past six months.

For sexually-active people, the guidelines also recommend that physicians encourage patients to use PrEP with other proven prevention strategies such as condoms to provide even greater protection than when used alone.

In July 2012, the Food and Drug Administration (FDA) approved Truvada for the use of prevention of HIV in high-risk populations. The announcement signifies the approval of first medication available for PrEP in the United States.

In August 2012, the CDC released interim guidance for clinicians considering the use of daily oral antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV infection in their heterosexually active patients in the CDC's Morbidity and Mortality Weekly Report (MMWR). The guidance complements the PrEP recommendations released in January 2011 for MSM and also provides guidance for heterosexual women and men, as well as a number of new recommendations for women of reproductive age and for couples in which one partner is HIV-positive and the other HIV-negative.

Research

In November 2010, the National Institutes of Health (NIH) announced the results of the iPrEx clinical trial, a large, multi-country research study examining PrEP. The study found that daily oral use of tenofovir plus emtricitabine (TDF/FTC, brand name Truvada) provided an average of 44% additional protection to men who have sex with men (MSM) who also received a comprehensive package of prevention.

In July 2011, a study by the Centers for Disease Control and Prevention (CDC) called the TDF2 study, provided evidence that a daily oral dose of antiretroviral drugs used to treat HIV infection can reduce HIV acquisition among uninfected individuals exposed to the virus through heterosexual sex.

In July 2011, a University of Washington study called Partners PrEP, found that two separate antiretroviral regimens – tenofovir and TDF/FTC – significantly reduced HIV transmission among sero-discordant couples, in which one partner is infected with HIV and the other is not (by 62 % and 73%, respectively). CDC co-managed two of the nine sites for this study.

In 2011, an NIH prevention clinical trial study called FEM-PrEP was halted early due to an independent monitoring committee concluding that the study was unable to demonstrate the effectiveness in preventing HIV infection in women enrolled in the trial.

The subject of PrEP as a policy issue is currently evolving debate in the scientific world. For more information on the subject, please visit our PrEP Policy Page, under the AAHIVM Policy and Advocacy tab.

Resources

For more information on efforts around PrEP implementation in the United States, visit: